Assoc Director, Statistical Programming

Role: Associate Director, Statistical Programming responsible for ensuring high-quality, efficient production of analysis datasets and statistical outputs supporting Gilead's clinical and regulatory activities. Responsibilities include collaborating with Clinical Development teams to meet project timelines, generating and overseeing programming deliverables for study reports and integrated summaries, and supporting regulatory submissions, including FDA and PMDA filings. The role involves designing analysis files, maintaining documentation, and leading strategic process improvements within the programming group. Requirements: BS in Biostatistics or Computer Science with 10+ years, MS with 8+ years, or PhD with 3+ years in pharma/biotech; extensive hands-on experience with SAS, CDISC standards, and regulatory submission activities. Preferred qualifications include experience in oncology, hematology, virology, and inflammation therapeutic areas, and familiarity with pivotal studies, integrated analyses, and global regulatory standards. The position demands strong communication, problem-solving skills, and the ability to manage complex, time-sensitive projects. High-value biopharma specifics: focus on clinical trial analysis programming, regulatory submission expertise, and experience with biologics or small molecules across various development stages. Work setup: not specified, but indicated as a senior, multi-year experience role.